The Effect of Branched-chain Amino Acid (BCAA) on the Pro... | NCT02327819

Studies
The Effect of Branched-chain Amino Acid (BCAA) on the Progression of Primary Liver Cancer

NCT02327819

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Dec 30, 2014Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Primary Liver Cancer

Interventions

Branched-chain amoni acids (BCAA)
non-BCAA protein supplement

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Dec 2015Estimated

Completion Date

Not provided

First Submitted Date

Dec 24, 2014

First Submission Date that Met QC Criteria

Dec 24, 2014

First Posted Date

Dec 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2014

Last Update Posted Date

Dec 30, 2014Estimated

Description Module

Brief Summary

Supplementation of BCAA found to reduce the risk of developing liver cancer, but the affect of BCAA on existing liver cancer is unknown.

The participants (post curative intent surgery) will be supplemented with either BCAA/non-BCAA-enriched protein supplement. The intervantion will go on for 2 years or until a new liver tumor is found.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BCAA supplement	Active Comparator	Branched-chain amino acids supplement, 12 g/day	Dietary Supplement: Branched-chain amoni acids (BCAA)
non-BCAA protein supplement	Sham Comparator	non-BCAA protein supplement	Dietary Supplement: non-BCAA protein supplement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Branched-chain amoni acids (BCAA)	Dietary Supplement		BCAA supplement
non-BCAA protein supplement

Measure	Description	Time Frame
time until a new liver tumor is found		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosed primary liver cancer
viral or Nonalcoholic Steatohepatitis Cirrhosis
Cirrhosis rated Child-Pugh A
liver cancer rated Barcelona Clinic Liver Cancer (BCLC) A

Exclusion Criteria:

Age (over 65)
liver condition rated Child-Pugh B/C
GI/Absorption issues
patients given a treatment before surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Nutrition Unit, Sourasky Medical Center		Tel Aviv		64239	Israel

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided